Application 103628

Type
BLA
Sponsor
BIOGEN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103628Avonexinterferon beta-1a351(a)Disc2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVONEXINTERFERON BETA-1AVIAL30UG/MLNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AvonexINTERFERON BETA-1ABiogen Inc.d70a39cc-de15-4c12-a1ec-8063b69ea0e12025-11-19Warnings, Adverse reactionsExact identifier
application number: BLA103628
ndc (product): 59627-333
ndc (product): 59627-002
ndc (product): 59627-003
ndc (product): 59627-222

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59627-002AvonexInterferon Beta-1aBiogen Inc.BLACurrent
59627-002AvonexInterferon Beta-1aBiogen Inc.BLACurrent
59627-002AvonexInterferon Beta-1aBiogen Inc.BLACurrent
59627-002AvonexInterferon Beta-1aBiogen Inc.BLACurrent
59627-002AvonexInterferon Beta-1aBiogen Inc.BLACurrent
59627-003Avonex PenInterferon Beta-1aBiogen Inc.BLACurrent
59627-003Avonex PenInterferon Beta-1aBiogen Inc.BLACurrent
59627-003Avonex PenInterferon Beta-1aBiogen Inc.BLACurrent
59627-003Avonex PenInterferon Beta-1aBiogen Inc.BLACurrent
59627-003Avonex PenInterferon Beta-1aBiogen Inc.BLACurrent
59627-111AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-111AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-111AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-111AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-111AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-111AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-111AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-111AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-222AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent
59627-333AVONEXinterferon beta-1aBiogen Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74948SUPPL 2023-07-31
74935SUPPL 2023-07-31
74934SUPPL 2023-07-31
69242SUPPL2021-11-05
69241SUPPL2021-11-05
69231SUPPL2021-11-05
62381SUPPL2020-03-31
62361SUPPL2020-03-30
59333SUPPL2019-07-15
59329SUPPL2019-07-15
59328SUPPL2019-07-15
18596SUPPL2015-12-28
9403SUPPL2015-12-23
39666SUPPL2014-09-03
39664SUPPL2014-09-03
39663SUPPL2014-09-03
31605SUPPL2014-09-03
31601SUPPL2014-09-03
31600SUPPL2014-09-03
18594SUPPL2014-09-03
9402SUPPL2014-09-03
31604SUPPL2013-03-15
18595SUPPL2013-03-15
31603SUPPL2012-02-29
31602SUPPL2012-02-29
39665SUPPL2012-02-27
18593SUPPL2012-02-27
18592SUPPL2007-02-23
31599SUPPL2007-02-12
43272SUPPL2004-03-11
39662SUPPL2004-03-11
39661SUPPL2004-03-11
31598SUPPL2004-03-11
18591ORIG2004-03-11
9401SUPPL2004-03-11
9400SUPPL2004-03-11
9399ORIG2004-03-11
57420ORIG1996-05-17